Securities code: 002755 securities abbreviation: Beijing Aosaikang Pharmaceutical Co.Ltd(002755) Announcement No.: 2022-025 Beijing Aosaikang Pharmaceutical Co.Ltd(002755)
About pemetrexed disodium for injection of subsidiaries
Announcement on conformity evaluation of generic drugs
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Jiangsu Beijing Aosaikang Pharmaceutical Co.Ltd(002755) Pharmaceutical Co., Ltd. (hereinafter referred to as the “subsidiary”), a wholly-owned subsidiary of Beijing Aosaikang Pharmaceutical Co.Ltd(002755) (hereinafter referred to as the “company”), recently received the notice of approval for supplementary drug application for pemetrexed disodium for injection approved and issued by the State Drug Administration (hereinafter referred to as the “drug administration”), The drug is approved to pass the consistency evaluation of quality and efficacy of generic drugs (hereinafter referred to as “consistency evaluation”). The relevant information is hereby announced as follows:
1、 Basic information of drugs
Drug name: pemetrexed disodium for injection
Dosage form: injection
Specification: 200mg (based on c20h21n5o6)
Registration category: Chemicals
Drug registration Standard No.: ybh02292021
Applicant: Jiangsu Beijing Aosaikang Pharmaceutical Co.Ltd(002755) Pharmaceutical Co., Ltd
Acceptance No.: cyhb2140508
Notice No.: 2022b00815
Approval conclusion: according to the drug administration law of the people’s Republic of China Opinions of the State Council on reforming the review and approval system of drugs and medical devices (GF [2015] No. 44), announcement on matters related to the evaluation of the quality and efficacy consistency of generic drugs (2017 No. 100) and announcement of the State Food and Drug Administration on the evaluation of the quality and efficacy consistency of generic drugs for chemical injection (2020 No. 62) After review, this product passed the consistency evaluation of quality and efficacy of generic drugs.
2、 Other relevant information of drugs
Pemetrexed is a multi-target anticancer folate antagonist, which inhibits cell replication by destroying the key folate dependent metabolic process necessary for cell replication. Pemetrexed, developed by Eli Lilly pharmaceutical, was listed in the United States and the European Union in 2004, Japan in 2007 and imported in China in 2006. Pemetrexed disodium for injection (AO Tiancheng) developed by the company was listed in China in 2009 and combined with cisplatin to treat locally advanced or metastatic non-small cell lung cancer or inoperable malignant pleural mesothelioma; Or single drug for the treatment of patients with locally advanced or metastatic non-squamous cell non-small cell lung cancer who have progressed after previous first-line chemotherapy. The company was approved to be listed in 500mg, 200mg and 100mg of pemetrexed disodium for injection in September 2018. In March 2021, 500mg and 100mg passed the consistency evaluation of generic drug quality and efficacy; The specification and efficacy of 200mg generic drug were approved in June 2021, and the quality evaluation was obtained recently.
The incidence rate of lung cancer is the highest in the world. The incidence rate of lung cancer is the highest in China. Over 85% of lung cancer in China is non-small cell lung cancer. Over 65% of lung cancer patients have developed to the late stage of diagnosis, and are not suitable for surgical resection. Over 50% of patients with early lung cancer have local recurrence or distant metastasis 1 years later. Pemetrexed, as a new generation of anti metabolic chemotherapy drugs, has high efficiency, low toxicity and broad spectrum anti-tumor activity. It has clear therapeutic effects on lung cancer, malignant pleural mesothelioma, breast cancer, pancreatic cancer and gastrointestinal cancer. PDB database shows that the sales of sample hospitals in China reached 1.6 billion yuan in 2019, nearly 1.3 billion yuan in 2020, and 1 billion yuan in the first three quarters of 2021. Among them, the sales of 200mg specification reached 900 million yuan in 2019, nearly 440 million yuan in 2020, and nearly 300 million yuan in the first three quarters of 2021, with great market potential.
3、 Impact on the company
According to relevant national policies, the varieties, quality and efficacy of drugs that have passed the consistency evaluation are equal to those of the original products, and appropriate support will be given in terms of medical insurance payment and medical institution procurement. In the context of the national policy of encouraging the priority purchase and use of products passing the conformity evaluation, the conformity evaluation of pemetrexed disodium 200mg for injection is conducive to further enhance the technical advantages of the drug, enhance the market competitiveness and expand the market share. At the same time, it has accumulated valuable experience for the subsequent consistency evaluation, product research and even generic drug development of the company and its subsidiaries.
4、 Risk tips
Due to the high-tech and high-risk characteristics of pharmaceutical products, the sales of drugs are affected by national policies, changes in market environment and other factors, with great uncertainty. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Beijing Aosaikang Pharmaceutical Co.Ltd(002755) board of directors February 25, 2022
